MXPA06005706A - A delivery system for active components as part of an endible composition having preselected tensile strength. - Google Patents

Abstract

A delivery system for inclusion in an edible composition is formulated to have at least one active component encapsulated within an encapsulating material, whereby the delivery system has a tensile strength suitable for delivering the active component at a desired release rate.

Description

High intensity sweeteners generally have a sweetening intensity higher than that of sugar (sucrose) and a caloric value lower than that of sugar at equivalent sweetness levels. It is especially advantageous to control the release of high intensity sweeteners in the compositions, since high levels of sweetness may displease the consumer. Moreover, the controlled release of the sweetener offers a convenient masking of unpleasant taste materials. Since each high intensity sweetener is chemically and physically different, each of them presents a challenge for use in an edible composition and each exhibits one or more drawbacks, which can be moderated by means of encapsulation. For example, many high intensity sweeteners lose their intensity of sweetness quickly when they are used in edible compositions such as chewing gums and sweets. The encapsulation can modulate and prolong the release in order to produce a more convenient flavor profile. Some high intensity sweeteners such as saccharin, stevioside, acesulfame-K, glycyrrhizin and thaumatin have a bitter taste or associated unpleasant leave. Certain high-intensity sweeteners are also unstable in the presence of certain chemicals, including aldehydes and ketones, and are sensitive to exposure to environmental conditions, including humidity. It is known that solid sucrose is darkened during prolonged storage when exposed to moisture and ambient air. Encapsulation can be used to isolate unstable compounds in order to prevent degradation and prolong shelf life.

Typically, the flavor profile of a high intensity sweetener can be described as a sudden burst of sweetness. Usually, high intensity sweeteners reach their peak of sweet taste quickly, after which the intensity of sweet taste declines in a short time. The initial rapid burst may be unpleasant for many consumers, since the strong sweet taste tends to prevail over the other flavors that may be present in the edible composition. The loss of relatively quick sweetness can also lead to a bitter aftertaste. For this reason, it is typically advisable to encapsulate high intensity sweeteners with an encapsulating material in order to modulate and prolong the rate of release and chemically stabilize and enhance the overall flavor profile. The selection of a suitable encapsulating material (i.e., polyvinyl acetate) has usually been concentrated on the molecular weight of the encapsulating material with higher molecular weights generally associated with longer release times. By way of example, U.S. Patent No. 4,771,1784 to Yang discloses a chewing gum composition containing a high molecular weight polyvinyl acetate mixed with a hydrophobic plasticizer as an encapsulating material. The encapsulating material is used to encapsulate an active ingredient such as aspartame. U.S. Patent No. 4,816,265 to Cherukuri et al. Discloses a sweetener delivery system, which uses a coating composed of an emulsifier and an encapsulant material of polyvinyl acetate or with a molecular weight of approximately 2,000 to 14,000. optionally in the presence of a wax. The coating is applied to the sweeteners like aspartame in order to execute the sustained release of the sweetener. U.S. Patent No. 5,057,328 issued to Cherukuri et al. Discloses an administration system for use, for example, in chewing gums, which consists of a food acid which is encapsulated in a matrix comprising an emulsifier and polyvinyl acetate in a specified molecular weight range. U.S. Patent No. 5,18,863 issued to Chau et al. Describes a system for administering sweetening agents with a prolonged release of! sweetener. The system uses a high intensity sweetener encapsulated in polyvinyl acetate with a molecular weight in the range of approximately 2,000 to 100,000. The system also includes the use of a plasticizing agent, a waxy material and an emulsifying agent. U.S. Patent No. 5,789,002 to Duggan et al. Describes a process for the preparation of sweeteners and acids as ingredients for chewing gum compositions. Specifically, the reference by Duggan et al. Describes the encapsulation of the sweetener or acid in a delivery system such as polyvinyl acetate. U.S. Patent Application No. 2002/0122842 filed by Seiestad et al. Discloses edible mixtures that include chewing gums containing at least two acids encapsulated by a polyvinyl acetate matrix. Polyvinyl acetate has a molecular weight in the range of about 20,000 to 120,000. The above-identified prior art systems prepare the encapsulation materials taking into account the selection of an encapsulating material (for example polyvinyl acetate) and its molecular weight. Since polyvinyl acetate is the most common encapsulating material, the molecular weight of the material becomes an essential factor in the preparation of prior art delivery systems. Consequently, the state of the art in regard to the encapsulation of active components, especially high intensity sweeteners, essentially associates the controlled release of the active component with the molecular weight of the encapsulating material. However, this approach is limited by the fact that the predictable modification of the controlled release of the active agent is only achieved by modifying the molecular weight of the encapsulating material. There is no predictable modification based on the use of other encapsulating materials and / or additives that can be employed in the preparation of suitable administration systems. Accordingly, there is no extensive approach that addresses the production of an advantageous delivery system that produces a convenient release rate of an active component without incurring a significant amount of trial and error experiments. Therefore, the introduction of a process for the production of administration systems for the convenient release of an active component so that, irrespective of the type of composition of the administration system, it is suitable for the administration of the system, would represent a significant advance in the art. specific application (for example, the controlled release of a high intensity sweetener). Summary of the invention The present invention presents a new approach for the controlled release of an active component in edible compositions such as, for example, chewing gum and confectionery compositions. The active components and materials used to encapsulate them produce a management system (or more than one administration system) that allows exceptional control of the release of the active component throughout a wide range of administration systems and takes into account the use of a range of encapsulation materials and additives that can be used to formulate the administration system. The delivery system is formulated based on its tensile strength as a fundamental factor in the formulation of a delivery system that can deliver a given active component at a convenient release rate. The encapsulated active components are preserved until the appropriate time for release and, therefore, are protected against moisture, reactive compounds, pH changes and the like. When the active component is a sweetener, the delivery system is adapted to the sweetener in order to produce a sustained sustained release, thus prolonging the period of sweetener release to produce an edible composition having a long lasting profile of pleasant taste, increased salivation and general utilization of the flavor imparted thereto without the disadvantage of prior art systems in which the sweetener may be released at a greater or lesser rate than is convenient. The present invention is based on the discovery that the tensile strength of an administration system produces a controlled release, prolonged and appropriate of an active component. As a result, a delivery system can be easily and quickly formulated using a wide range of materials (eg, encapsulating agents, active components and additives) with the appropriate characteristics to obtain a certain rate of release. The active components and materials used to encapsulate them produce a delivery system that offers exceptional control of the release of the active component. It has been found, in accordance with the present invention, that an administration system for active components can be produced based on the tensile strength of! isthmus of administration that has a specific tensile strength as compared to a standard. This approach differs from that of prior art systems that focus on a characteristic (molecular weight) of one of the materials (encapsulating material) used to produce the delivery system. In this manner, a delivery system is formulated to express a desired release profile by adjusting and modifying the tensile strength by means of the specific selection of the active component, the encapsulating material, the additives, the amount of the active component and the like. , which can be compared to at least one, typically a plurality of standard delivery systems, each of which has a known release rate. Once a suitable tensile strength is chosen, any administration system having the appropriate tensile strength can be used without having to be limited to a specific encapsulating material and its molecular weight. The formulation process can be extended to encapsulating materials that exhibit physical and chemical properties similar to those of the encapsulating material that is part of the standard delivery system. In the present context, the term "tensile strength" refers to the maximum effort that a matter! under a stretch load it can resist without tearing. A standard method for measuring the tensile strength of a given substance is that defined in the American Society of Testing Materials in the method number ASTM-D638. According to the present invention, the selection of a desired tensile strength within a convenient range allows the production of edible compositions using a wide range of materials, including encapsulating materials without having to be limited to a specific encapsulating material and without limiting only to the modification of the release rate by means of the selection of a molecular weight for the encapsulating material.

BRIEF DESCRIPTION OF THE DRAWINGS The following drawings are illustrative of the embodiments of the present invention and are not intended to limit the invention encompassed by the claims forming part of the application. Figure 1 is a graph comparing the intensity of perceived sweetness of three chewing gum samples during a 30 minute period according to the present invention; Figure 2 is a graph comparing the perceived sweetness intensity of two chewing gum samples, each of which contains a delivery system with different tensile strength over a 30 minute period according to the present invention; Figure 3 is a graph comparing the percentage of aspartame retained over a period of time by two samples of chewing gum containing delivery systems with different tensile strengths according to the present invention and Figure 4 is a graph that compares the intensity of perceived bitterness of two samples of chewing gum, each of which contains a delivery system with different tensile strength according to the present invention. Detailed Description In one aspect of the present invention, there is provided an administration system for inclusion in an edible composition such as a chewing gum composition or a confectionery composition having at least one active component encapsulated by an encapsulating material, wherein the administration system has a tensile strength of at least 6,500 psi and typically in the range of about 6,500 psi to 200,000 psi. In another aspect of the present invention there is provided an edible composition such as a chewing gum composition or a confectionery composition comprising at least one edible composition forming component and a delivery system comprising at least one encapsulated active component. inside an encapsulating material, where the administration system has a tensile strength of at least 6,500 psi. In another aspect of the present invention, there is provided a method for preparing an objective delivery system for an edible composition, comprising combining at least one active component, at least one encapsulating material and, optionally, at least one additive, to obtain a preselected tensile strength of the target delivery system based on the comparison of the tensile strength of at least one sample delivery system having the same or a similar active component and a known release rate of the active component . A method for the preparation of a target delivery system for an edible composition is also presented which serves to administer at least one active component at an intended release rate, which method comprises the step of encapsulating the at least one active component in an encapsulating material so as to give the target delivery system a tensile strength of at least 6,500 psi. In addition, a method for the preparation of a target delivery system for an edible composition serving to administer at least one active component at an intended release rate is presented, which method comprises encapsulating the at least one active component in a encapsulating material so as to confer on the target delivery system a tensile strength associated with the intended release rate, allowing the delivery system to release the at least one active component of the edible composition at the intended release rate. A method for preparing an edible composition containing an objective delivery system that serves to administer at least one active component at an intended release rate is further presented., method comprising encapsulating the at least one active component in an encapsulating material so as to confer on the target management system a tensile strength associated with the intended release rate, allowing the delivery system to release at least an active component of the edible composition at the intended release rate and adding the target release system to the edible composition. Edible compositions containing the present administration system are also presented. While one embodiment of the present invention relates to chewing gum compositions, confectionery compositions and beverages, the present invention may be used to produce a variety of edible compounds including, but not limited to, food products, foods , compositions with nutrient content, pharmaceutical products, nutritional drug, vitamins and other products that can be prepared for consumption by a user. Because the administration system can be easily incorporated into the edible composition, the edible compositions that can benefit from it and that fall within the scope of the present invention cover a wide range, as indicated above. "administration system" employed in this answer is intended to encompass the encapsulating material and a single active component encapsulated therein, as well as other additives employed to form the administration system described below. It is to be understood that the edible compositions of the present invention may contain a plurality of administration systems, wherein each administration system contains a single active component. The term "encapsulating material" should encompass any one or more edible water-insoluble materials with any ability to form a coating or solid film as a protective barrier around the active component. The present invention relates, in general, to a delivery system as defined herein for use in edible compositions, comprising an encapsulating material and an active component encapsulated by the encapsulating material. The delivery system of the present invention is formulated with a predetermined predetermined tensile strength to produce the constant controlled release of the active component for a preselected period of time such as a prolonged period of time. This period of time varies depending on the type of product in which the administration system is incorporated. A person skilled in the art, based on the present description, can adjust the administration system to obtain the desired effect. A prolonged period of time relates, in the present context, to an increased release of the active ingredient of the administration system over a longer period of time than that of the systems described above and which may be at least 15 minutes, including at least 20 minutes, at least 25 minutes, at least 30 minutes, as well as all values and ranges comprised therein, for example preferably from 25 to 30 minutes or more. Moreover, the administration system of the present invention further presents a way not only of administering active agents for a prolonged period of time but also of maintaining an increased intensity of the active ingredient over a prolonged period of time. For example, if the active ingredient is a flavor or a sweetener. In one aspect of the present invention, the amount of active ingredient released may vary over the extended period of time. For example, at an early stage of administration, the amount of active component released (based on the total amount present in the delivery system at that time) may be greater than the amount of active component released during subsequent periods or Subsequent (based on the total amount present in the administration system at that time). In an embodiment, the prolonged period of time results in the retention of at least about 5% of the at least one active component after 30 minutes from the start of the administration of the active component in the edible composition, such as at the beginning of chewing a chewing gum composition, including at least 10%, 1 5%, 20%, 25%, 30% or more after 30 minutes. In another embodiment, the prolonged period of time results in the retention of at least about 10% of the at least one active component after 20 minutes from the start of administration of the active component in the edible composition, including at least about 1 5%, 20%, 25%, 30%, 40%, 50% or more after 20 minutes. In another embodiment, the prolonged period of time results in the retention of at least about 30% of the at least one active component after 15 minutes from the start of administration of the active component in the edible composition, including at least about 30%, 40%, 50%, 60%, 70%, 75% or more after 1 5 minutes. In another embodiment by the use of sweetener in a chewing gum, for example, the prolonged period of time results in an intensity of perceived sweetness during at least the whole of the aforementioned period, for example at least about 1 5 minutes , at least approximately 20 minutes, at least 30 minutes, etc. from the beginning of the chewing of the chewing gum composition. The predetermined tensile strength is determined based, in part, on the active component and the intended release time thereof. The predetermined tensile strength of a Standard composed of one or more delivery systems can be selected, where each standard delivery system has a known release rate of the active component required. The administration system of the present invention further confers on the active component a barrier against moisture and other conditions such as changes in pH, reactive compounds and the like, the presence of which may inconveniently degrade the active component. The delivery system facilitates the controlled release of the active component in a wide variety of edible compositions, including chewing gum compositions, food products, confectionery compositions, pharmaceutical compositions, beverages, foods, compositions with nutrient content, vitamins, drugs nutritional and similar. The administration system is developed in accordance with the present invention so as to have a suitable tensile strength that can be selected, depending in part on the active component and the desired release rate of the active component, of a system standard. of known administration containing the active component at known release rates. The active components that can be incorporated as part of the delivery system can be selected from among sweeteners, including high intensity sweeteners, acids, flavors, pharmaceuticals, therapeutic agents, vitamins, refreshing agents. breath, cooling agents and other materials that would benefit by coating them for protection, controlled release and / or masking flavors. Among the active components is nicotine, useful for the treatment of addiction to tobacco products and caffeine, typically found in coffee and / or cola drinks. In a specific form of the present invention. The active component is a sweetener, for example a high intensity sweetener such as neotame and aspartame. It has been found, according to the present invention, that a delivery system can be formulated for the administration of an active component so as to ensure sustained effective release of the active component based on the type and amount of the active component and the desired release speed. For exampleIt may be advisable to effect the controlled release of a high intensity sweetener in a period of 25 to 30 minutes to ensure that there is no rapid outbreak of sweetness that may be offensive to some consumers. A shorter period of controlled release may be more convenient for other types of active components such as pharmaceuticals or therapeutic agents, which can be incorporated into the same edible composition using separate administration systems for each active component. In accordance with the present invention, the delivery systems can be formulated with a certain tensile strength associated with a range of release rates, based on a standard. The standard may comprise a series of known delivery systems with tensile strengths in a range ranging, for example, from low to high values of tensile strength. Each of the standard delivery systems is associated with a specific release rate or ranges of release rates. Thus, for example, a delivery system with a relatively low release rate can be formulated, manufacturing a delivery system with relatively high tensile strength. Conversely, compositions of lower tensile strength tend to exhibit relatively high release rates. A factor of the present invention is that the tensile strength of the administration system is directly associated with the rate of release of the active component without directly taking into account the type or molecular weight of the encapsulating material. In one embodiment, the present invention includes the incorporation of a plurality of delivery systems in order to deliver a plurality of separate active components, including active components that can be conveniently released at clearly different delivery rates. For example, high intensity sweeteners may conveniently be released over an extended period of time (eg, 20 to 30 minutes) while some pharmaceutical products are conveniently released over a considerably shorter period of time. In certain embodiments of the present invention, the administration system can be prepared in such a way that the release of the at least one active ingredient is carried out at specific rates in relation to the time of administration. For example, in one embodiment, the administration system can be prepared in such a way that the release of the at least one active agent is carried out at a rate of 80% in the course of 15 minutes, 90% in the course 20 minutes and / or 95% in the course of 30 minutes. In another embodiment, the delivery system can be prepared in such a way that one or more active agents are released at a rate of 25% over the course of 15 minutes, 50% 'in the course of 20 minutes and / or 75% in the course of 30 minutes. In one embodiment of the present invention, a method for selecting an objective delivery system containing an active component for an edible composition is presented. The method includes, in general, the preparation of a system, of intended administration containing an active component, an encapsulating material and optional additives, wherein the intended delivery system has a preselected tensile strength. The tensile strength of the intended delivery system is preselected in order to result in a convenient release rate of the active component. The selection of the tensile strength is based on the tensile strengths of sample administration systems having the same or a similar active component and known release rates of the active component. In another embodiment of the invention, the method comprises the steps of (a) obtaining a plurality of administration systems comprising an active component, at least one encapsulating material and optional additives, where each of the systems of administration has a different tensile strength.; (b) analyzing the sample delivery systems to determine the respective release of the component and (c) formulating an objective delivery system containing the same active component with a tensile strength corresponding to a convenient release rate of the active component on the base of the sample administration systems obtained. It will be understood that, in this way, a plurality of administration systems, each of which contains a different active component, can be prepared using a comparison with standard delivery systems containing said different active components. The method of selecting at least one suitable delivery system for incorporation into an edible composition can begin by determining a convenient release rate for an active component (i.e., a first active component). The determination of the convenient release rate can be carried out according to literature or technical references or by in vitro in vivo tests. Once the desired release rate is determined, it is normal to determine the desired tensile strength (i.e., the first tensile strength) for a delivery system (i.e., a first delivery system) which can then release the first active component at the desired release rate. Once obtained the administration system that can administer the active component as necessary, it is chosen for its eventual inclusion to an edible composition. The above-described method can then be repeated for a second active component and for other active components as described, by the determination and selection of a suitable administration system. The present method can be used in connection with the formulation of the target delivery system using encapsulating materials having similar physical and chemical properties, including the degree of water solubility, the affinity for the active component and similar properties used in the system samples. of administration. Applicants have discovered that by maintaining the tensile strength of the delivery system within a convenient range, the active ingredient is released from the composition in a very controlled and constant manner irrespective of the specific type of encapsulating materials employed. By focusing on the tensile strength of the delivery system, the process for selecting and formulating suitable management systems is enhanced so that the need for trial and error experimentation typically required in administration systems is effectively reduced. of the prior art. The present invention allows, for example, the formulation of a suitable target administration system, which focuses on a single variable (i.e., tensile strength) and, therefore, takes into account all components of the administration system, including encapsulating materials and any additives (eg fats and oils) that can be conveniently added to the formulation and allows the delivery system to release the active component at a convenient rate of release when incorporated into a composition edible. The convenient tensile strength of the delivery system can be easily determined within a wide advantageous range. In one embodiment of the present invention, the tensile strength of the delivery system is at least 6,500 psi, including 7500. 10,000. 20,000. 30,000 40,000. 50,000. 60,000. 70,000. 80,000. 90,000 100,000. 1 25,000. 135,000. 1 50,000. 1 65,000. 175,000. 1 80,000. 1 95,000. 200,000 and all ranges and subranges comprised between them, for example a tensile strength of 6,500 to 200,000 psi. The formulation of a delivery system with a suitable tensile strength can be made starting from a variety of encapsulating materials and at least one additive referred to as "at least one modifying or modifying agent., of the tensile strength. "The at least one additive can be used to formulate the delivery system by modifying the tensile strength of the delivery system, including tensile strength reducing materials such as fats, emulsifiers, plasticizers (softeners), waxes, low molecular weight polymers and the like, the use of materials that increase the tensile strength of the administration system can be adapted by combining different modifiers of the tensile strength to form the system. For example, the tensile strength of high molecular weight polymers such as polyvinyl acetate can be reduced or when tensile reducing agents such as fats and / or oils are used. embodiment of the present invention, at least one modifier of the tensile strength is present in the administration system in a sufficient amount so as to release the one or more active agents contained in the delivery system at a rate of 80% in the course of 1 5 minutes, 90% in the course of 20 minutes and / or 95 % in the course of 30 m inutes. In another embodiment, the at least one tensile modifier is present in the delivery system in a sufficient amount so as to release the one or more active agents contained in the delivery system at a rate of 25 seconds. % in the course of 1 5 minutes, 50% in the course of 20 minutes and / or 75% in the course of 30 minutes. In another embodiment of the present invention, at least one tensile modifier is present in the delivery system in a sufficient amount such that the tensile strength is at least about 6,500 psi, including 7500. 1 0.000. 20,000. 30,000 40,000. 50,000. 60,000. 70,000. 80,000. 90,000 100,000. 125,000 1 35,000. 1 50,000. 1 65,000. 1 75,000. 1 80,000. 1 95,000. 200,000 And all the ranges and subranges comprised between them, for example a tensile strength of 6,500 to 200,000 psi. Examples of modifiers or tensile modifiers include, but are not limited to, fats (eg, hydrogenated or unhydrogenated vegetable oils, animal fats), waxes (eg, microcrystalline wax, beeswax). ), plasticizers / emulsifiers (eg mineral oil, fatty acids, mono- and diglycerides, triacetin, glycerin, acetylated monoglycerides, glycerol monostearate glycol ethers), low and high molecular weight polymers (eg, polypropylene glycol, polyethylene glycol) , polyisobutylene, polyethylene, polyvinylacetate) and the like, as well as combinations thereof. It is also possible to refer to plasticizers as softeners. Therefore, by employing tensile strength modifiers, the general tensile strength can be adjusted or modified. administration system in such a way that a preselected tensile strength can be obtained for the corresponding desired release rate of the active component of the edible composition compared to a standard. The administration system of the present invention typically occurs in the form of powder or granules. The particle size may vary, in general, and not have a significant effect on the function of the present invention. In one embodiment, the average particle size is conveniently selected according to the desired rate of release and / or palatability (i.e., roughness) and the type of vehicle incorporated into the edible composition. Accordingly, in certain embodiments of the present invention, the average particle size is from about 75 to about 600, including 100. 1 1 0. 140. 1 70. 200. 230. 260. 290. 320. 350. 370 and all values and ranges included among those values. Since the values are an average, it will be appreciated that within a given sample of powder or granules, there may be many particles with sizes larger and / or smaller than the numerical values presented. In an embodiment of the present invention, in which the delivery system is incorporated into a chewing gum, the particle size may be less than 600 microns. Except where otherwise indicated, the amount of ingredients incorporated into the compositions according to the present invention is designated in terms of% by weight based on the total weight of the composition. The delivery systems of the present invention produce the controlled release of the active components according to the need by means of! use of a preselected tensile strength that matches a convenient release rate selected according to the type of active component to be encapsulated, the encapsulating material employed, the additives that are incorporated, the desired release rate of the active component and the like. The materials used to encapsulate the active component are selected, in general, from water-insoluble materials capable of forming a strong matrix, solid coating or film as a protective barrier around the active component. The encapsulating material is chosen to match the tensile strength of the delivery system which can be at least 6,500 psi, including 7500. 1 0.000. 20,000. 30,000 40,000. 50,000. 60,000. 70,000. 80,000. 90,000 100,000. 1 25,000. 1 35,000. 1 50,000. 1 65,000. 1 75,000. 1 80,000. 1 95,000. 200,000 and all ranks and subranks comprised therein, for example a tensile strength of 6,500 to 200,000 psi. Such encapsulating materials can be selected from polyvinyl acetate, polyethylene, cross-linked polyvinyl pyrrolidone, polymethyl methacrylate, polylactic acid, polyhydroxy alkanoates, ethyl cellulose, polyvinyl acetatophthalate, polyethylene glycol esters, methacrylic acid-co-methyl methacrylate and the like, as well as combinations thereof. The encapsulating material may be present in amounts of about 0.2% to 10% by weight based on the total weight of the edible composition, including 0.3, 0.5, 0.7, 0.9, 1.0. 1 .25, 1 .4, 1 .7, 1 .9, 2.2, 2.45, 2.75, 3.0. 3.5, 4.0. 4.25, 4.8, 5.0. 5.5, 6.0. 6.5, 7.0. 7.25, 7.75, 8.0. 8.3, 8.7, 9.0. 9.25, 9.5, 9.8 and all values and ranges comprised between said values, for example from 1% to 5% by weight. The amount of encapsulating material must depend in part, of course, on the amount of the active component that must be encapsulated. The amount of encapsulating material with respect to the weight of the delivery system is from about 30% to 99%, including 35, 40. 45, 50. 55, 60. 65, 70. 75, 80. 85, 95, 97 and all the values and ranges comprised between the same, for example from about 60% to 90% by weight. The tensile strength of the delivery system can be selected from relatively high tensile strengths when a relatively low release rate and relatively low tensile strengths are desired when a higher release rate is desired. Accordingly, when a tensile strength of 50,000 is employed for a delivery system, the release rate of the active component generally has to be less than the release rate of the active component in an administration system having a resistance to traction of 1 0.000 psi, regardless of the type of encapsulating material (for example polyvinyl acetate) used. In one embodiment of the present invention, the encapsulating material is polyvinyl acetate. A representative example of a polyvinyl acetate product suitable for use as an encapsulating material in the present invention is Vinnapas® B 1 00. marketed by Wacker Polymer Systems of Adrián, Michigan. A delivery system using polyvinyl acetate can be prepared by melting a sufficient amount of polyvinyl acetate at a temperature of about 65 ° C to 120 ° C for a short period of time, for example 5 minutes. The melting temperature depends on the type of tensile strength of the polyvinyl acetate encapsulating material, where materials with higher tensile strength generally melt at higher temperatures. Once the encapsulating material is melted, a suitable amount of the active component (for example, a high intensity sweetener such as aspartame) is added and added to the melt completely or for a short period of additional mixing. The mixture thus obtained is a semi-solid mass, which is then cooled (for example at 0 ° C) to obtain a solid and then milled to a standard US sieve size of about 30 to 200 (600 to 75 microns). ). The tensile strength of the administration system obtained according to ASTM-D638 can be easily analyzed. The selection of a suitable encapsulating material will also depend in part on! type and quantity of the active component and the presence of other additives or ingredient. Plasticizers or softeners, as well as fats and oils, for example, act as "tensile modifiers" and can be incorporated into the delivery system and, in particular, into the encapsulating material, to modify the resistance to the traction of the administration system thus obtained. The aforementioned additives can be added to the encapsulating material during the melting step. Naturally, the amount of additives used in the administration system of the present invention varies according to the desired tensile strength, although typically it is in the range of 40% by weight based on the total weight of the administration system ..

By formulating the delivery system so that it has a predetermined tensile strength, the active component in the material can be completely encapsulated! encapsulant or incompletely encapsulated within the encapsulant, provided that the tensile strength obtained from the administration system meets the criteria set forth above. Incomplete encapsulation can be achieved by modifying and / or adjusting the manufacturing process to obtain partial coverage of the active component. It has been found that the presence of fats and oils as an additive has two effects on the delivery system. The first effect is observed at lower concentrations, that is up to 5% by weight, including up to 4.7, up to 4.5, up to 4.25, up to 4.0. up to 3.5, up to 3.0 up to 2.5, up to 2.25, up to 2.0. up to 1.75, up to 1.5, up to 1.0 and all the values and ranges comprised between them, where the fats and / or oils maintain or increase the tensile strength of the administration system. At higher concentrations (ie, typically greater than 5% by weight), fats and / or oils tend to reduce the tensile strength of the delivery system. Even with those unusual or non-linear effects on the tensile strength of the delivery system, a suitable delivery system can easily be formulated with the desired release of! active component according to the present invention, since the target delivery system is prepared on the basis of model delivery systems having known release rates for the active component. While the present disclosure relates to sweeteners, it is to be understood that the effect of tensile strength on the delivery system is similar regardless of the active component. The sweetening agents used can be selected from a wide range of materials, including water-soluble sweeteners, water-soluble artificial sweeteners, water-soluble sweeteners derived from naturally-occurring water-soluble alcohols, dipeptide-based sweeteners and protein-based sweeteners, including mixtures thereof. . Without intending to be limited to any specific sweetener, representative categories and examples include: (a) water-soluble sweetening agents such as dihydrochalcones, monelin, stevioside, glycyrrhizin, dihydroflavenol, and sugar alcohols such as sorbitol, mannitol, maltitol, and ester amides of the aminoalkenoic acid of L-aminodicarboxylic acid such as those described in U.S. Patent No. 4,619,834, the disclosure of which is incorporated herein by reference, and mixtures thereof. (b) water-soluble artificial sweeteners such as soluble salts of saccharin, ie salts of sodium and calcium saccharin, citrate salts, salts of acesulfame such as the sodium, ammonium or calcium salt of 3,4-dihydro-6-methyl- 1, 2, 3-oxatiazin-4-one-2,2-dioxide, the potassium salt of 3,4-dihydro-6-methyl-1, 2,3-oxathiazin-4-one-2,2-dioxide (Acesulfame-K), the free acid form of saccharin and mixtures thereof. (c) dipeptide-based sweeteners such as sweeteners derived from L-aspartic acid such as the methyl ester of L-aspartyl-L-phenylalanine (Aspartame) and the materials described in U.S. Pat. 3,492.1 31, hydrate of L-aifaaspartil-N- (2, 2,4,4-tetramethyl-3-tietanyl) -D-alaninamide (Alitame), methyl esters of L-aspartyl-L-phenylglycerin and L-aspartil -L-2, 5-d-hydrophenyl-glycine, L-aspartyl-2, 5-dihydro-L-phenylalanine, L-aspartl-L- (1-cyclohexen) -alanine, neo-alan and mixtures thereof. (d) water-soluble sweeteners derived from water-soluble sweeteners of natural origin such as steviosides, chlorinated derivatives of common sugar (sucrose), for example chlorodeoxysugar derivatives such as chlorodeoxysucrose or chlorodeoxygalactosucrose derivatives known, for example, under the product designation Sucralose; examples of derivatives of dorodeoxysaccharose and chlorodeoxygalactosucrose include, but are not limited to, 1-chloro-1'-deoxysucrose; 4-chloro-4-deoxy-aifa-D-galactopyranosyl-alpha-D-fructofuranoside or 4-chloro-4-deoxygalactosucrose; 4-chloro-4-deoxy-alpha-D-galactopyranosyl-1-chloro-1-deoxy-beta-D-fructo-furanoside or 4,1 '-dichloro-4,1' -dideoxygalacto-sucrose; 1 ', 6'-dichloro 1', 6'-dideoxysucrose; 4-Chloro-4-deoxy-alpha-D-galactopyranosyl-1,6-dichloro-l, 6-dideoxy-beta-D-fructofuranoside or 4,1 ', 6'-trichloro-4,1', 6'- tridesoxygalactosucrose; 4,6-dichloro-4,6-dideoxy-alpha-D-galactopyranosyl-6-chloro-6-deoxy-beta-D-fructofuranoside or 4,6,6'-trichloro-4,6,6'-trideoxygalactosucrose; 6, 1 ', 6'-trichloro-6,1', 6'-trideoxysucrose; 4,6-dichloro-4,6-dideoxy-alpha-D-galacto-pyranosyl-1,6-dichloro-1,6-dideoxy-beta-D-fructofuranoside or 4,6,1,6'-tetrachloro-4 , 6, 1 ', 6'-tetradeoxygalacto-sucrose; and 4.6, 1 ', 6'-tetradesoxysucrose and (e) sweeteners based on proteins such as thaumaoccous danielli (Thaumatin I and I I), talin. The intense sweetening agents can be used in many different physical forms well known in the art to produce an initial burst of sweetness and / or a prolonged sweetness sensation. Without being limited thereto, said physical forms include the free forms such as the spray dried, powdered and granulated forms, the encapsulated forms and mixtures thereof. In one embodiment, the sweetener is a high intensity sweetener such as aspartame, sucralose and acesulfame potassium (Ace-K). The active component (e.g. sweetener) that is part of the delivery system can be used in amounts necessary to impart the desired effect associated with the use of the active component (e.g., sweetness). With respect to their presence in the administration system, the active components may be present in amounts of about 1% to 70% by weight based on the total weight of the delivery system,. even of 5, 1 0. 1 5, 20. 25, 30. 35, 40. 45, 50. 55, 60. 65% by weight and all the values and ranges comprised between said values, for example of approximately 10% to 40% by weight based on the total weight of the administration system. In the case of typical edible compositions including chewing gum compositions, confectionery compositions and beverage compositions, the sweeteners may be present in amounts of about 0.1% to 6% by weight based on the total weight of the composition, including 0.5, 1, 2, 3, 4, 5% by weight and all values and sub-ranges comprised between said values, for example from about 0.5% to 3% by weight. The active component, especially when the active component is a sweetener, may be present in the edible composition in the free form, depending on the intended release profile. In another aspect of the present invention, edible compositions comprising the present administration system and a vehicle are presented in an appropriate amount to give rise to the system of administration. The term "vehicle" as used herein refers to a vehicle acceptable to the oral route such as the soluble and insoluble components of a chewing gum composition capable of mixing with a delivery system and causing no damage to the patient. warm-blooded animals, including humans. The vehicles further include components of the composition that can be mixed without significant interaction with the delivery system. In one of the embodiments of the present invention, the edible composition is a chewing gum composition with prolonged release (eg, typically at least 15 minutes) of the active component. The chewing gum composition comprises a chewing gum base and the delivery system of the present invention comprising an encapsulating material and at least one encapsulated active component such as, for example, a sweetener or a flavoring. The delivery system is present in amounts of about 0.2% to 10% by weight based on the total weight of the chewing gum composition, including 0.5, 1.0. 2.0. 3.0. 4.0. 5.0. 6.0 7.0 8.0. 9.0% by weight, including all values and sub-ranges comprised between said values, for example from about 1% to 5% by weight. The present invention can be incorporated into a variety of processes for preparing chewing gum compositions as is known to those skilled in the art. Such chewing gum compositions can be and include a variety of different formulations that are typically used to prepare chewing gum products. Typically, a chewing gum composition contains a base portion of chewable gum, which is essentially free of water and is water-insoluble and a portion of water-soluble dough. The water-soluble portion is generally released from the base portion of gum within a period of time during chewing. The base portion of gum is retained in the mouth during the whole chewing time. The non-water-soluble gum base generally comprises elastomers, elastomeric solvents, plasticizers, waxes, emulsifiers and inorganic fillers. Also included are plastic polymers such as polyvinyl acetate, which behave somewhat similar to plasticizers. Other plastic polymers that can be used include polyvinyl laurate, cross-linked polyvinylpyrrolidone and polyhydroxyalkanoates. The elastomers may constitute from about 5% to 95% by weight of the gum base. In another embodiment, the elastomers may constitute from about 10% to 70% by weight of the gum base and, in another embodiment, from 15% to 45% by weight of the gum base. Examples of elastomers include synthetic elastomers such as polyisobutylene, polybutylene, isobutylene-isoprene copolymers, styrenebutadiene copolymers, polyvinyl acetate, and the like. The elastomers may also include natural elastomers such as natural rubber, as well as natural gums such as jelutong, lechi caspi, goatee, massaranduba balata, chewing gum, gutta hang kang or combinations thereof. There are other elastomers known to those skilled in the art. The elastomeric plasticizers modify the firmness of the finished rubber when they are used in the rubber base. Elastomeric plasticizers are typically present in an amount of up to 75% by weight of the gum base. In another embodiment, the elastomeric plasticizers are present in an amount of about 5% to 45% by weight of the gum base and in another embodiment of about 10% to 30% by weight of the gum base. Examples of elastomeric plasticizers include natural rosin esters such as glycerol ester of partially hydrogenated rosin, glycerol ether of vegetable resin rosin, partially hydrogenated rosin pentaerythritol esters, partially hydrogenated methyl and methyl esters and the like. Synthetic elastomeric plasticizers such as terpene resins may also be employed in the composition of the gum base. The waxes include synthetic waxes of natural origin such as polyethylene, beeswax, carnauba and the like. You can also use petroleum waxes such as paraffin. The waxes may be present in an amount of up to 30% by weight of the gum base. The waxes contribute to the curing of the finished gum and help to improve the flavor release and can also extend the shelf life of the product.

Elastomeric solvents are often resins such as terpene resins. Plasticizers, sometimes called softeners, are typically fats and oils, including tallow, hydrogenated vegetable oils and cocoa butter. The rubber base also typically includes a load component. The charging material component modifies the texture of the rubber base and contributes to processing. Examples of such fillers include magnesium aluminum silicates, clay, alumina, talc, titanium oxide, cellulose polymers and the like. The fillers are typically present in an amount of 1% to 60% by weight. Emulsifiers, which sometimes also have plasticizing properties, include glycerol monostearate, lecithin and glycerol triacetate. In addition, the gum bases may also contain optional ingredients such as anti-oxidants, colors and flavors. The insoluble gum base may be present in an amount of about 5% to 95% by weight of the chewing gum. In one embodiment, the insoluble gum may be present in an amount of about 10% to 50% by weight of the gum base and in another embodiment of about 20% to 40% by weight of the gum base.

Softeners are added to the chewing gum to optimize the chewing ability and the palate sensation of the gum. Softeners, also known in the art as plasticizers or plasticizers, are generally present in amounts of about 0.5% to 15% by weight based on the total weight of the chewing gum composition. The softeners contemplated by the present invention include, for example, lecithin. Furthermore, aqueous solutions of sweeteners such as those containing sorbitol, hydrogenated starch hydrolyzate, corn syrup and combinations thereof as softeners and binders in gum may be used. The chewing gum compositions of the present invention may be coated or uncoated and may be in the form of tablets, bars, granules, beads and the like. The composition of the different forms of the chewing gum compositions is similar, but may vary with respect to the proportion of the ingredients. For example, coated rubber compositions may contain a lower percentage of softeners. The granulates and balls have a small core of chewing gum, which is then coated with a sugar solution or a sugar-free solution to create a hard shell. Tablets and sticks are usually formulated so that they have a softer texture than the chewing gum core. According to one aspect of the chewing gum composition of the present invention, the administration system is added during the manufacture of the chewing gum composition. In another aspect of the present invention, the administration system is added in one of the last steps, for example the last step in the formation of the chewing gum composition. Applicants have determined that this modification of the process incorporates the delivery system to the rubber composition without literally adhering the delivery system to it as may occur if the delivery system is mixed directly with the gum base. Accordingly, the administration system, while only weakly contained in the gum composition, can effectively release the active component thereof during a typical chewing action. Accordingly, an important portion of the delivery system is free of the gum base and the corresponding ingredients of the chewing gum. Coating techniques for the application of a coating for a chewing gum composition, such as tub and spray coating, are well known. In one embodiment, the coating can be employed with solutions adapted to generate a hard candy layer. Both sugar and sugar alcohols can be used for this purpose, together with high intensity sweeteners, colorants, flavorings and binders. Other components can be added in minor amounts to the coating syrup and include moisture-wicking compounds, anti-tack compounds, dispersing agents and film-forming agents. Suitable moisture-absorbing compounds for use in coating syrups include mannitol or dicalcium phosphate. Examples of useful antiadhesion compounds, which may also function as fillers, include talc, magnesia trisilicate and calcium carbonate. These ingredients can be employed in amounts of about 0.5% to 5% by weight of the syrup. Examples of dispersing agents, which may be employed in the coating syrup, include titanium dioxide, talc or other titanium compounds, talc or other adherent compounds according to the above. Usually the coating syrup is heated and a portion of it is deposited on the cores. Usually a single deposition of the coating syrup. it is not sufficient to produce the desired amount or thickness of the coating and a second, third or more layers of the coating syrup may be applied to accumulate the weight and thickness of the coating at the desired levels with layers, allowing them to dry between layers. A method for preparing the chewing gum composition of the present invention is carried out by successively adding the various ingredients of the chewing gum including the delivery system of the present invention to any commercially available mixer known in the art. Once the ingredients are thoroughly mixed, the rubber base of the mixer is discharged and the desired shape is obtained, for example by lamellating it into sheets and rods, extruding to form lumps or cutting it to form pellets. In general, the ingredients are mixed by melting the gum base, first, and adding it to the mixer in operation. You can also melt the base in the mixer itself. You can also add colors or emulsifiers at this time. A softener can be added to the mixer at this time, along with the syrup and a portion of the volumetric agent. Then more parts of the volumetric agent are added to the mixer. Flavorings are typically added with the final portion of the volumetric agent. Finally, the administration system exhibiting a predetermined tensile strength is added to the mixture thus obtained. Other optional ingredients are added to the batch in a typical manner, well known to those skilled in the art. The entire mixing procedure typically takes five to fifteen minutes, although longer mixing times may be necessary. Those skilled in the art will recognize that numerous variations of the above described methods can be followed. Once the ingredients are mixed, a variety of shapes and products can be formed with the gum mass. For example, granules or balls can be formed with the ingredients and used as cores to prepare a coated chewing gum product. However, any type of chewing gum can be used with the present invention. If a coated product is desired, the coating may contain ingredients such as flavors, artificial sweeteners, dispersing agents, coloring agents, film formers and binding agents. Flavors contemplated by the present invention include those commonly known in the art such as essential oils, synthetic flavors or mixtures thereof, including, but not limited to, oils derived from plants and fruits such as citrus oils, fruit essences, oil of peppermint, spearmint oil and other peppermint oils, clove oil, wintergreen oil, anise and the like. Flavors can also be added to the coating syrup in an amount such that the coating can be present in amounts of about 0.2% to 1.2% by weight of the flavoring agent. In another embodiment, the coating may be present in amounts and more preferably from about 0.7% to 1.0, &; in weight of the flavoring agent. Dispersing agents are often added to the syrup coatings in order to bleach and reduce adhesion. The dispersing agents contemplated by the present invention for use in the coating syrup include titanium dioxide, talc or any other non-stick compound. The dispersing agent can be added to the coating syrup in an amount such that the coating contains from about 0. 1% to 1.0%, including 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 and all values and ranges comprised therein, for example from about 0.3% to 0.6% by weight of the agent. Coloring agents can be added directly to the coating syrup in the form of tincture or lacquer. The coloring agents contemplated by the present invention include food grade dyes. Film formers can be added to the coating syrup, among which are methylcellulose, carboxymethylcellulose, ethylcellulose, hydroxyethylcellulose and the like, as well as combinations thereof. Binding agents can be added either as an initial coating over the center of chewing gum or they can be added directly to the coating syrup. The binding agents contemplated by the present invention include gum arabic, gum talha, gelatin, vegetable gums and the like. The binding agents, when added to the coating syrup, are typically added in amounts of about 0.5% to 10% by weight. The present invention also encompasses confectionery compositions containing the delivery system of the present invention. Confectionery compositions include, for example, compressed tablets such as mints, heat-hardened candies, chocolates, chocolate-containing products, nutritional bars, chews, jellies, filled confections, cake covers, fried products, consumable thin films and other compositions that fall within the accepted general definition of confectionery compositions. Confectionery compositions in the form of compressed tablets such as mints can generally be prepared by combining sugar or a finely screened sugar substitute, a flavoring agent (eg, peppermint flavor), a volumetric agent such as gum arabic and a optional coloring agent. The flavoring agent, the volumetric agent are combined and then the sugar or sugar substitute is added gradually together with a coloring agent, if necessary. The product is then granulated by passing it through a sieve of a desired mesh size (eg, 12 mesh) and then dried, typically at temperatures of about 55DC to 60DC. The powder thus obtained is fed to a tabletting machine equipped with a large punch and the granules obtained are broken into granules and then pressed. Candies boiled at high temperatures typically contain sugar or sugar substitute, glucose, water, flavoring agent and an optional coloring agent. The sugar is dissolved in the water and then glucose is added. The mixture is heated until it reaches a boil. The liquid thus obtained, to which a colored agent may have been previously added, is poured onto an oiled sheet and cooled. Then add the flavoring agent and knead it into the cooled dough. The mixture thus obtained is then fed to a free fall roller arrangement known in the art to form the final shape of the hard candy. A chew composition typically includes two main components, a high boil and an ice cream. As an example, egg albumen or a substitute is mixed with water and beaten to form a light foam. Sugar and glucose are added to the water and typically boiled at temperatures of about 130 ° C to 140 ° C and the boiled product thus obtained is poured into a mixing machine and beaten until it becomes creamy. The beaten albumen and the flavoring agent are combined with the creamy product and then the combination is thoroughly mixed. More details can be found with respect to the preparation of confectionery compositions in Skuse Complete Confectioner (138 Edition) (1 957) including pages 41 -71, 1 33-144 and 255-262; and Sugar Confectioner Manufacture (2nd Edition) (1995), E. B. Jackson, Editor, p. 129-168, 169-1 88, 1 89-216, 21 8-234 and 236-258, each of which is incorporated herein by reference. EXAMPLE 1 The following study illustrates the effect of the presence of oil or fats on the total tensile strength of an embodiment of the administration system of the present invention. The rate of release of the active component (i.e., aspartame) is affected by the variation of the tensile strength, such that the rate of release of the delivery system of higher tensile strength is generally less than the speed of delivery. Release of formulations with lower tensile strength. When relatively large amounts of oil are used, the tensile strength of the delivery system is generally reduced, which increases the release rate of the active component. In contrast, typically reduced amounts of fats or oils are used for delivery systems with higher tensile strength exhibiting lower release rates. Experimental Procedure Preparation of administration systems Four administration systems were prepared to administer a high intensity sweetener (ie, aspartame) containing varying amounts of polyvinyl acetate and oils or fat, according to the formulations set forth in Table 1 Table 1 The polyvinyl acetate was melted at a temperature of about 10 ° C in a continuous extruder. Hydrogenated oil and glycerol monostearate were added to the molten polyvinyl acetate. Then aspartame was added to the mixture thus obtained and mixed under high cut to completely disperse the ingredients. The extruded product was cooled as obtained and then reduced to a particle size of less than 420 microns to produce the corresponding delivery system containing the high intensity sweetener encapsulated aspartame as the active component. The tensile strength of the final delivery systems was measured according to the ASTM D638-02A standard and is reported in Table 1. As indicated in Table 1, the addition of fats and oils exhibits two effects on the tensile strength of the delivery system when a portion of the encapsulating material (polyvinyl acetate) is replaced by fats and oils. As demonstrated by the comparison of the administration system No. 3 with the administration system No. 4, there is an abrupt increase in the tensile strength when replacing 5% by weight of polyvinyl acetate by the corresponding amounts of fats and oils . When the replacement is 10% by weight, the tensile strength drops significantly but remains above the level of the delivery system which does not contain fat or oils (administration system No. 1). When fats and oils are used in relatively large amounts (i.e. 20% by weight), the delivery system tends to exhibit a much lower tensile strength as compared to administration system No. 3). Preparation of the chewing gums Three chewing gum sample compositions were prepared using the ingredients listed in Table 2 and incorporating administration systems Nos. 1 to 3 as set forth in Table 1. Table 2 I ngredient Chewing gum Chewing gum Chewing gum 1 2 3 Gum base 39.0 39.0 39.0 Sorbitol 42.8 42.8 42.8 Mannitol 9.0 9.0 9.0 Flavor 4.67 4.67 4.67 Glycerin 1 .5 1 .5 1 .5 Lecithin 0.2 0.2 0.2 System 2.83 - -administration 1 System - 2.83 - administration 2 System - - 2.83 administration 3 The chewing gum composition was prepared as follows. The gum base was melted at a suitable temperature in a mixer. Then the rest of the ingredients were added to the molten gum base and mixed until the total dispersion of all the ingredients was achieved. It was reduced to the chewing gum composition thus obtained to the appropriate size and it was conditioned for approximately 1 week and evaluated using a group of people. Each person was asked to taste the chewing gum compositions by chewing each of the samples listed in Table 2 and rating the sweetness intensity of each sample at 10 minute intervals over the course of a 30 minute period. . Figure 1 shows the data obtained. Results As illustrated in Figure 1, gum 3, prepared with administration system No. 3, free of grease and oil, provided a prolonged sweetener release, with a higher intensity of the sweetener being determined in each of the ranges , in comparison with gums 1 and 2, each of which contained a system of administration with a certain level of fat and oil. The gum 1, prepared with the administration system No. 2, which exhibited the lowest tensile strength due, in part, to its higher fat and oil content, had a relatively short duration of the sweetener release and exhibited the lower intensity of the sweetener after the initial release, determined in each of the 10 minute intervals. It should be noted that each of the chewing gum compositions prepared according to Example 1 could be modified to include one or more additional delivery systems, each of which contains a different active component. EXAMPLE 2 The following study examined the relationship between the tensile strength of the delivery system and the rate of release of the encapsulated active component. The presence of fats or oils was varied to modify the tensile strength of the delivery system, thus allowing adjustment of the rate of release of the encapsulated active component according to convenience. Experimental Procedure Preparation of Management Systems Four administration systems were prepared using the Ingredients listed in Table 3. Table 3 Ingredient System System System Administration System 5 Administration 4 Administration 6 Administration 7 Polyvinyl acetate (65% high 65% tensile strength) Polyvinyl acetate (low 63% 63% tensile strength) Hydrogenated oil 15% 3.5% 15% 3.5% Glycerol monostearate 5% 1.5% 5% 1.5% Aspartame 17% 30% Acesulfame-K 17% 30% Tensile strength 6,500 42,900 * ** (psi) * was not measured but is believed to be similar to the non-delivery system. 5 ** was not measured but is believed to be similar to the administration system no. 6 The administration systems discussed above (ie administration systems Nos. 4 to 7) were prepared in the following manner. The polyvinyl acetate encapsulating materials were melted at a temperature of about 10 1 ° C in a continuous extruder. Hydrogenated oil and glycerol monostearate were added to the molten encapsulating materials. The sweetener was then added to the obtained mixture. The mixture was intimately mixed under high cut to completely disperse the ingredients and give an extruded product. The mixed extruded product was then allowed to cool and crushed to give particles of the respective delivery systems with a particle size of less than 600 microns. Each of the systems of administration was formed so as to exhibit a specific tensile strength, based in part on the amount and strength of the polyvinyl acetate and the amount of fats and oils and similar components. The tensile strength of each of the administration systems Nos. 4 to 7 is reported in Table 3. Preparation of chewing gum samples Two test samples were prepared from the chewing gum compositions to which in the present is called gums 4 and 5, with the ingredients listed in the following Table 4. Gum 4 was formulated with a combination of the systems of administration Nos. 5 and 6, set forth in Table 3, in the amounts stipulated to give a chewing gum with a relatively low tensile strength management system. The gum 5 was formulated with a combination of administration systems Nos. 4 and 7 in the stipulated amounts to produce a chewing gum with a relatively high tensile strength administration system. Table 4 Each of the chewing gums test samples were prepared as follows. The rubber base was melted in a mixer. The rest of the ingredients were added to the molten gum base. The molten gum base was mixed to completely disperse the ingredients. The chewing gum thus obtained was allowed to cool. The chilled chewing gum was reduced in size and conditioned for approximately one week. It should be understood that each of the chewing gum compositions prepared according to Example 2 could easily be modified to include one or more systems of additional administration, each of which contains a different active component. Panel of Descriptive Evaluation Analysis of Sweetness and Bittering I nity A group of people met to test and grade the sweetness intensity of the chewing gum samples over time. Each person was asked to taste the chewing gum compositions by chewing each of the test samples, gums 4 and 5, for a period of 30 minutes. At each 5-minute interval, subjects were asked to evaluate the intensity of perceived sweetness in the chewing gum tested on a scale of 1 to 1 0. The results are recorded in Figure 2. In addition to measuring the intensity of sweetness perceived by people during chewing, people were also asked to assess the intensity of perceived bitterness in chewing gum on a similar scale from 1 to 1 0. The results are recorded in Figure 4. Residual Sweetener Analysis Chewing gums chewed by people were also subjected to chemical analysis at intervals of 5 m inutes in order to measure the amount of residual sweetener left in the rubber bolus. Every 5 minutes for a period of 30 minutes, the bolus of the chewing gum of each person was recovered and analyzed by high performance liquid chromatography (H PLC). The results are shown in Figure 3. Results Descriptive panel results: As illustrated in Figure 2, the intensity of perceived sweetness of gum 4, which contained the administration system of lower tensile strength was significantly reduced with more faster than gum 5, which contained the system of management with the highest tensile strength in a period of 30 minutes. From the data presented in Figure 2, it appears that the high tensile strength administration systems tend to prolong the duration of the sweetener release from the chewing gum. As illustrated in Figure 4, the results indicate that gum 5, which possessed the administration system with the highest tensile strength, exhibited an initial perceived bitterness relatively higher than that of gum 4 (ie, with the administration system with lower tensile strength). However, in the course of the next 20 minutes, the perceived bitterness in the rubber 5 (higher tensile strength) was reduced over time, while the perceived bitterness (lower tensile strength) increased over time and remained above the bitter intensity of the gum 5. The results indicate that the rate of release of the sweetener affects the perception of the inherent bitter taste that may normally be present in the chewing gum compositions. The lower release rate of the sweetener from gum 5 (higher tensile strength) prolonged the duration of taste masking over the course of 25 minutes, thus reducing the perception of bitter taste compared to gum 4 (lower resistance). to traction). Human chewing to the end / Residual aspartame As illustrated in Figure 3, gum 4, which contains a delivery system with a relatively lower tensile strength, exhibited a greater rate of sweetener release than gum 5, containing an administration system with a relatively higher tensile strength over a period of 30 minutes. Consequently, by increasing the tensile strength of the delivery system, a lower rate of release of the sweetener can be achieved. Conversely, reducing the tensile strength of the delivery system increases the rate of release of the sweetener. Chewing gum 4 with the administration system with relatively less tensile strength exhibited a lower residual amount of aspartame in the chewed bolus compared to the gum 5, with the administration system with relatively higher tensile strength. Accordingly, the data indicate that systems of administration with higher tensile strength generally confer a lower release rate of sweeteners. The results set forth in Figure 3 coincide with the results set forth in Figure 2 with respect to the fact that faster release of the sweetener results in less retention of the sweetener in the gum over time. The foregoing description details and describes embodiments

Claims (1)

1. merely exemplary of the present invention. A person skilled in the art will readily recognize, in light of said description, and the claims that accompany it, that various changes and modifications may be made thereto without departing from the spirit and scope of the invention, as defined in the following claims. REIVI NDICATIONS 1. A delivery system comprising at least one active component encapsulated within an encapsulating material, delivery system having a tensile strength of at least 6,500 psi. 2. The delivery system according to claim 1, wherein the tensile strength of the delivery system is from about 6,500 psi to 200,000 psi. The administration system according to claim 1, wherein the edible composition is selected from the group consisting of a food product, a pharmaceutical composition, a food, a composition with nutrient content, a vitamin, a nutritional drug product and combinations thereof. The administration system according to claim 1, wherein the edible composition is selected from a food product, a pharmaceutical composition, a food, a nutrient content composition, a vitamin, a nutritional drug product and combinations of the same. The administration system according to claim 1, wherein the encapsulating material is selected from the group consisting of polyvinyl acetate, polyethylene, cross-linked polyvinylpyrrolidone, polymethylmethacrylate, polylactic acid, polyhydroxyalkanoates, ethylcellulose, polyvinyl acetaphthalate, esters of polyethylene glycol, methacrylic acid-co-methyl methacrylate and the like, as well as combinations thereof. The administration system according to claim 1, wherein the encapsulating material is present in an amount of 30% to 99% by weight based on the total weight of the delivery system. 7. The administration system according to claim 1, wherein the encapsulating material is present in an amount of 60% to 90% by weight based on the total weight of the delivery system. 8. The administration system according to claim 1, wherein the active component is selected from the group consisting of a sweetener, an acid, a flavoring, a pharmaceutical, a therapeutic agent, a vitamin, a breath freshener, an agent refreshing and combinations thereof. The administration system according to claim 1, wherein the active component is a high intensity sweetener. The administration system according to claim 8, wherein the active component is a sweetener and is selected from the group consisting of an amino acid sweetener, a dipeptide sweetener, glycyrrhizin, saccharin, a saccharin salt, an acesulfame salt, a cyclamate, a stevioside, a talin, a dihydrochalcone compound, a chlorinated sucrose polymer and combinations thereof. eleven . The administration system according to claim 9, wherein the high intensity sweetener is selected from the group consisting of neotame, aspartame, sucralose and a mixture thereof. 12. The administration system according to claim 8, wherein the active component is present in an amount of about 1% to 70% by weight based on the total weight of the delivery system. The administration system according to claim 1, wherein the active component is present in an amount of about 10% to 40% by weight based on the total weight of the delivery system. The administration system according to claim 1, further comprising a tensile strength modifying agent. 1 5. The administration system according to claim 14, in which the modifier of the tensile strength is selected from the group consisting of a fat, an emulsifier, a plasticizer, a softener, a low molecular weight polymer, a high molecular weight polymer, a wax and combinations of the same. The administration system according to claim 14, wherein the tensile modifier is selected from the group consisting of a hydrogenated oil, a glycerol monostearate, a wax, a low weight polymer molecular, triacetin, glycerin, an ester of rosin and combinations thereof. The administration system according to claim 14, wherein the tensile modifier is present in an amount of up to 40% by weight based on the total weight of the delivery system, 18. The administration system according to claim 1 in the form of particles or granules. 1 9. The administration system according to the claim 18, in which the particles or granules have a particle size of up to 600 microns. 20. The administration system according to the claim 19, in which the particles or granules have a particle size of 75 to 600 microns. twenty-one . An edible composition comprising at least one component that forms the edible composition and a delivery system according to claim 1. 22. The edible composition according to claim 21, selected from the group consisting of a chewing gum composition, a food product, a confectionery composition, a pharmaceutical composition, a beverage, a food, a composition containing nutrients, a vitamin, a nutritional drug product and a combination thereof. 23. The edible composition according to claim 21. wherein the encapsulating material is present in an amount of about 0.2% to 10% by weight based on the total weight of the edible composition. 24. The edible composition according to claim 22, which is a chewing gum composition and wherein the at least one edible forming component comprises a gum base. 25. The edible composition according to claim 24, wherein the tensile strength of the delivery system is from about 6,500 psi to 200,000 psi. 26. The edible composition according to claim 24, wherein the encapsulating material is present in an amount of about 30% to 99% by weight based on the total weight of the delivery system. 27. The edible composition according to claim 24, wherein the active component is selected from the group consisting of a sweetener, an acid, a flavoring, a pharmaceutical, a therapeutic agent, a vitamin, a breath freshener, a refreshing agent and combinations thereof. 28. The edible composition according to claim 24, wherein the active component is present in an amount of about 1% to 70% based on the total weight of the delivery system. 29. The edible composition according to claim 24, wherein the encapsulating material further comprises a tensile modifier. 30. The edible composition according to claim 29 in which the tensile modifier is selected from! group formed by. a fat, an emulsifier, a plasticizer, a softener, a low molecular weight polymer, a high molecular weight polymer, a wax and combinations thereof. 31 The edible composition according to claim 22, which is a candy and comprising a candy vehicle. 32. The edible composition according to claim 31, wherein the tensile strength of the delivery system is from about 6,500 to 200,000 psi. 33. The edible composition according to claim 31, wherein the material! The encapsulant is present in an amount of about 30% to 99% by weight based on the total weight of the delivery system. 34. The edible composition according to claim 31, wherein the active component is selected from the group consisting of a sweetener, an acid, a flavoring, a pharmaceutical, a therapeutic agent, a vitamin, a breath freshener, a refreshing agent and combinations thereof. 35. The edible composition according to claim 31, wherein the active component is present in an amount of about 1% to 70% based on the total weight of! administration system. 36. The edible composition according to claim 31. wherein the encapsulating material further comprises a tensile modifier. 37. The edible composition according to claim 36. wherein the tensile modifier is selected from the group consisting of a fat, an emulsifier, a plasticizer, a softener, a low molecular weight polymer, a high molecular weight polymer, a wax and combinations thereof. same. 38. A method for the preparation of a target delivery system for an edible composition, comprising combining at least one active component and at least one encapsulating material to obtain a preselected tensile strength of the target delivery system based on the Comparison of the tensile strength of at least one administration system shows that it has the same or similar active component and a known release rate of the active component. 39. The method according to claim 38, further comprising obtaining a preselected tensile strength based on comparison with a plurality of sample delivery systems. 40. The method according to claim 38, further comprising: (a) obtaining a plurality of sample administration systems comprising the at least one active component and the at least one encapsulating material, wherein each of said systems Sample administration has a different tensile strength; (b) evaluate the sample delivery systems to determine the respective release rates of the active component and (c) formulate the target delivery system containing the same or similar active component with a corresponding tensile strength at the desired release rate of the active com ponent on the basis of the systems of adm instration. 41 The method according to claim 38, wherein the additive is a modifier of the tensile strength. 42. The method according to claim 38, wherein the tensile strength of each sample delivery system is at least 6,500 psi. 43. The method according to claim 38, further comprising: determining a desired release rate for the at least one active component of the edible composition; determining a tensile strength associated with the desired release rate; formulating the administration system for the at least one active component based, at least in part, on the tensile strength. 44. The method according to claim 43, wherein the tensile strength is at least 6,500 psi. 45. The method according to claim 43, wherein the target delivery system includes at least one additive. 46. The method according to claim 43 further comprising: associating a different tensile strength for each of a plurality of release rates of each of a plurality of different active components. 47. A method for the preparation of the delivery system according to claim 1, comprising encapsulating the parison minus an active component in the encapsulating material. 48. A method for preparing an edible composition having at least one active component that releases the at least one active component at a desired release rate, which method comprises: encapsulating the at least one active component in less an encapsulating material for forming an objective delivery system with a tensile strength of at least 6,500 psi and adding the target delivery system to the edible composition. 49. A method for selecting at least one suitable delivery system for incorporation into an edible composition, wherein each of said delivery systems comprises an active component encapsulated within an encapsulating material, wherein said method comprises: determining a rate of desired release for a first active component of the edible composition; determining a first tensile strength for a first delivery system associated with said desired release rate and selecting a first delivery system for said first active component based, at least in part, on said tensile strength. 50. The method according to claim 49, further comprising: determining a second desired release rate for a second active component of the edible composition; determining a second tensile strength for a second delivery system associated with said desired release rate and selecting a second delivery system for said second active component based, at least in part, on said second tensile strength. 51 The method according to claim 50 further comprising repeating the steps of determining a desired release rate, determining a desired tensile strength and selecting a delivery system for at least one additional active component of the edible composition. . 52. The method according to claim 51, wherein the tensile strength is at least 6,500 psi. 53. The method according to claim 51, wherein the administration system further comprises at least one additive. 54. The method according to claim 53, wherein the additive is a modifier of the tensile strength. 55. The method according to claim 51, wherein the determination of the desired tensile strength comprises: associating a different tensile strength for each of a plurality of release rates of said at least one active component . 56. The method according to claim 55, wherein the determination of the desired tensile strength comprises: associating a different tensile strength for each of a plurality of release rates for each of the plurality of components assets. 57. The method according to claim 55, further comprising: determining a desired tensile strength for each of a plurality of delivery systems. 58. A method for the preparation of an objective delivery system for an edible composition, which serves to administer at least one active component at a desired release rate, which method comprises encapsulating the at least one active component in an encapsulating material. so as to confer on the target delivery system a target tensile strength associated with the desired release rate, allowing the delivery system to release the at least one active component of the edible composition at the desired release rate. 59. The method according to claim 58, wherein the objective tensile strength is at least 6,500 psi. 60. The method according to claim 60 which comprises a) determining the desired release rate of the active component; b) determining the objective tensile strength of the first delivery system with the ability to administer the at least one active component at the desired release rate and c) formulating the target delivery system containing the at least one active component with the Target tensile strength. 61 A method for the preparation of an edible composition containing an objective delivery system which serves to administer at least one active component at a desired release rate, which method comprises encapsulating the at least one active component in an encapsulating material of so as to confer on the target delivery system a target tensile strength associated with the desired release rate, allowing the delivery system to release the at least one active component of the edible composition at the desired release rate and add the system of objective administration to the edible composition. 62. The method according to claim 38, which further comprises combining at least one additive with the at least one active component and at least one encapsulating material. 63. The administration system according to claim 1, wherein the tensile strength of the admi- nistration system is at least about 1 0.000 psi. 64. The administration system according to claim 1, wherein the tensile strength of the adm inistration system is at least about 22,000 psi. 65. The administration system according to claim 1, wherein the tensile strength of the adm inistration system is at least about 24,000 psi. 66. The administration system according to claim 1, wherein the tensile strength of the adm inistration system is at least about 42,000 psi. 67. The edible composition according to claim 21, comprising at least two administration systems. 68. The edible composition according to claim 67, wherein each of the at least two delivery systems comprises at least two different active components. 69. The edible composition according to claim 67, wherein at least one active agent is a sweetener and a second active agent is a flavoring. 70. The edible composition according to claim 66, wherein each of the at least two delivery systems has a different tensile strength. 71 A chewing gum composition comprising a gum base and at least one active component encapsulated within an encapsulating polymeric material, wherein the active component is released for at least 15 minutes, once the chewing of the composition has begun. 72. The chewing gum composition according to claim 71, wherein the active component is released for at least 20 minutes, once the chewing of the composition has begun. 73. The chewing gum composition according to claim 71, wherein the active component is released for at least 30 minutes, once the chewing of the composition has begun. 74. The chewing gum composition according to claim 71, wherein the release of the active component varies during at least 15 minutes. 75. The chewing gum composition according to claim 71, wherein the at least one active component encapsulated within an encapsulating polymeric material has a tensile strength of more than 6,500 psi. 76. The chewing gum composition according to claim 71, wherein the at least one active component encapsulated within an encapsulating polymeric material has a tensile strength of more than 1 0.000 psi. 77. The administration system according to claim 16, wherein the modifier of the tensile strength is a fat. 78. The administration system according to claim 77, wherein the fat is present in an amount of up to 5% by weight of the delivery system. 79. The administration system according to claim 14, wherein the modifier of the tensile strength is an oil. 80. The administration system according to claim 79, wherein the oil is present in an amount of up to 5% by weight of the delivery system. 81 The administration system according to claim 14, comprising two tensile modifiers and tensile modifiers are a fat and an oil. 82. The administration system according to claim 80. wherein the combination of fat and oil is present in an amount of up to 5% by weight of the delivery system. 83. A chewing gum composition comprising a gum base and at least one sweetener encapsulated within an encapsulating polymeric material, where the sweetener is perceived by a consumer for at least 15 minutes, once the chewing of the composition has begun. 84. The chewing gum composition according to claim 83, wherein the sweetener is perceived by a consumer for at least 20 minutes, once the chewing of the composition has begun. 85. The chewing gum composition according to claim 83, wherein the sweetener is perceived by a consumer for at least 30 minutes, once the chewing of the composition has begun. 86. The chewing gum composition according to claim 83, wherein the at least one active component encapsulated within an encapsulating polymeric material has a tensile strength greater than 6,500 psi. 87. The chewing gum composition according to claim 83, wherein the at least one active component encapsulated within an encapsulating polymeric material has a tensile strength greater than 1 0.000 psi. 88. The edible composition according to claim 33, wherein the encapsulating material is present in an amount of about 60% to 90% by weight based on the total weight of the delivery system. 89. The edible composition according to claim 35, wherein the active component is present in an amount of about 10% to 40% by weight based on the total weight of the delivery system. 90. The edible composition according to claim 89, wherein the active component is present in an amount of about 0. 1% to 6% by weight based on the total weight of the delivery system. 91 The edible composition according to claim 89, wherein the active component is present in an amount of about 0.5% to 3% by weight based on the total weight of the delivery system. 92. A chewing gum composition comprising at least one gum base, a delivery system and at least one active component encapsulated within the delivery system, wherein the delivery system comprises at least one additive in one. sufficient amount so that at least about 50% of the at least one active component is maintained within the delivery system for at least 15 minutes after the start of chewing of the chewing gum composition. 93. A chewing gum composition comprising at least one gum base, a delivery system and at least one active component, wherein the at least one active agent is released from the delivery system at a rate of minus 25% after 1 5 minutes from the start of the chewing of the chewing gum composition. 94. A delivery system, comprising at least one encapsulating material, at least one active component and at least one additive, wherein the at least one additive is present in the delivery system in an amount sufficient for the at least one active agent is released in a proportion of at least 25% after 15 minutes of administration.